Liquid pharmaceutical products for application to a patient by a syringe are typically packaged in containers which are sealed with a stopper inserted into a neck of the container. A metallic cap seal is typically applied over the exterior opening of the neck to cover the end of the rubber stopper. The cap seal is secured to the neck by crimping the cap seal around a shoulder of the neck. The cap seal includes a small diameter hole at its center, facilitating the insertion of a needle of the syringe into the container. Limited amounts of information about the product may be imprinted on the cap seal.
A removable overcap is sometimes attached over the cap seal. The overcap may display limited amounts of product information such as the container's contents, brand name, dosage or strength of the medication in the container. The mechanism for attaching the overcap to the cap seal is expressly designed to be altered when the overcap removed from the cap seal, thus preventing replacement of the overcap on the cap seal. Consequently, the absence of the overcap on a container is a positive indication that access to the medicament or tampering of the container has been attempted. Such an overcap is described in U.S. Pat. No. 5,377,853.
The process of preparing containers of medicaments for shipment to a distributor typically includes steps of: (1) sterilizing an empty container, (2) filling the container with a medicament, (3) placing the rubber stopper in the neck of the container, (4) attaching the overcap to the cap seal, (5) sealing the end of the container with the cap seal/overcap assembly, (6) sterilizing the sealed container and (7) labeling the container with the contents of the container and other information related to the manufacturing history.
Particularly in the case of containers holding medicaments, it is of the utmost importance that the information on the labeling of each container correspond to the actual contents of the container and include such information that allows for traceability of the contents to the history of manufacture. Thus, information should ideally be associated with each filled container from near the moment that the container is filled.
Presently, however, it is not possible to include with each container at the time of filling, all of the required information on the container contents and on manufacturing the container contents, since labeling applied to the container at the time of filling would not survive the autoclaving step following filling, and there is insufficient room on the cap seal and/or on the overcap to include all of the required information. Further, the destination for each filled container is not known at the time the container is filled. Since the minimum information to be applied to a label is generally prescribed by law, and such laws vary from country to country, the labeling of containers can not be done until the destination of a particular lot of containers is determined. Such determination may not be made until after a specific lot of the containers has been shelved for a period of time. In order to reliably determine the contents of the containers in a lot that has been shelved, samples from each lot are generally taken from the shelved lot and the contents of the samples determined analytically prior to labeling. Such a procedure is time consuming and expensive.
A further problem associated with labeling of the containers is one of counterfeiting. Such counterfeiting may utilize packaging and labeling identical to legitimate articles such that even an experienced end user pharmacist or medical practitioner is unable distinguish the counterfeit article from the legitimate article.
Accordingly, there is a need for a method of tagging a container of medicament with information which provides: (1) a high level of confidence that the labeling on a container reflects the actual contents of the container, and (2) a high level of confidence that the container was filled by the manufacturer identified on the label. Preferably, the method of tagging would allow for the tagging to be applied substantially concurrently with the filling of the container with medicament such that sampling of the containers in a shelved lot would be unnecessary. Preferably, the method of tagging would also provide for storing information related to not only the container contents, but also information related to packaging and distribution of the individual containers.